도라지
Platycodon grandiflorus
📚 관련 논문 (14편)
1. Phytomedicine. 2021 Dec;93:153811. doi: 10.1016/j.phymed.2021.153811. Epub 2021 Oct 19. An 8-week randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of red Platycodon grandiflorus root extract on enhancement of immune function. Park EJ(1), Jung AJ(2), Lee
2. Oncol Rep. 2026 May;55(5):83. doi: 10.3892/or.2026.9088. Epub 2026 Mar 6. Platycodin D sensitizes head and neck squamous cell carcinoma to cisplatin by inducing autophagy arrest. Bae M(1), Lee MK(1), Jeong MG(2), Lee Y(1), Joo H(1), Lee YC(2), Lee JW(3), Kim SI(2), Ko SG(4), Eun YG(1). Autho
3. Chin J Nat Med. 2025 Jul;23(7):848-862. doi: 10.1016/S1875-5364(25)60913-7. Platycodon grandiflorus polysaccharides combined with hesperidin exerted the synergistic effect of relieving ulcerative colitis in mice by modulating PI3K/AKT and JAK2/STAT3 signaling pathways. Liu Y(1), Sun Q(1), Xu
4. Biomed Pharmacother. 2019 Dec;120:109496. doi: 10.1016/j.biopha.2019.109496. Epub 2019 Oct 11. Platycodon grandiflorus enhances the effect of DDP against lung cancer by down regulating PI3K/Akt signaling pathway. Li Y(1), Wu Y(2), Xia Q(1), Zhao Y(1), Zhao R(3), Deng S(4). Author information
5. Nutrients. 2019 Oct 14;11(10):2445. doi: 10.3390/nu11102445. Intervention Study on the Efficacy and Safety of Platycodon grandiflorus Ethanol Extract in Overweight or Moderately Obese Adults: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial. Kim YJ(1), Kwon EY(2)(3), Kim JW
1. Front Pharmacol. 2024 Mar 14;15:1162883. doi: 10.3389/fphar.2024.1162883. eCollection 2024. Efficacy of botanical lozenges in the treatment of chronic pharyngitis: a randomized controlled trial. Wu Y(#)(1)(2), Zhang F(#)(1)(2)(3)(4), Kuang D(#)(2)(5), Li D(1)(2)(3), Yan J(1)(3), Yang J(1)(3), Wang Q(1)(3), Wang Y(1)(3), Sun J(1)(3), Liu Y(1)(3), Xia Y(1)(3), Cao H(1)(2)(3)(6). Author information: (1)Nutritional Department, Affiliated Hospital of Jiangnan University, Wuxi, China. (2)Wuxi School of Medicine, Jiangnan University, Wuxi, China. (3)Clinical Assessment Center of Functional Food, Affiliated Hospital of Jiangnan University, Wuxi, China. (4)Yixing Institute of Food and Biotechnology Co., Ltd., Yixing, China. (5)Nursing Department, Affiliated Hospital of Jiangnan University, Wuxi, China. (6)Department of Endocrinology, Affiliated Hospital of Jiangnan University, Wuxi, China. (#)Contributed equally Background: In clinical practice, antibiotics and/or inhaled or oral hormone preparations are the first line of treatment for chronic pharyngitis. However, this therapeutic regimen is not satisfactory enough. At present, medicinal plants as dietary supplements or functional foods are widely recognized for the treatment and prevention of different diseases. Purpose: This study aimed to evaluate the efficacy of the botanical lozenge made from several medicinal plant extracts in the treatment of chronic pharyngitis and its effects on patients' illness perception and adherence to treatment. Methods: Patients with chronic pharyngitis were randomly assigned to the experimental group (n = 52) or the control group (n = 51). Patients were given botanical lozenges prepared from the extracts of medicinal plants such as Siraitia grosvenorii (Swingle) C. Jeffrey ex A.M.Lu and Zhi Y. Zhang [Cucurbitaceae; Siraitiae fructus], Lonicera japonica Thunb [Caprifoliaceae; Lonicerae japonicae flos], Platycodon grandiflorus (Jacq.) A. DC [Campanulaceae; Platycodon radix], and Glycyrrhiza uralensis Fisch. ex DC [Fabaceae; Glycyrrhizae radix et rhizoma] or placebos made of starch for 15 days. The improvement of pharyngeal symptoms and signs, illness perception, and adherence to treatment were evaluated at the end of the intervention. Results: The total score of pharyngeal symptoms of patients in the experimental group (3.33 ± 2.33) was significantly lower than that in the control group (5.20 ± 2.93) (p < 0.01). In comparison to the control group (3.43 ± 1.43), the total pharyngeal signs score of patients in the experimental group (2.69 ± 1.59) was considerably lower (p < 0.01). The improvement rates of pharyngeal itching, dry throat, pharyngeal foreign body sensation, aggravation due to excessive speaking, and congestion of pharyngeal mucosa in the experimental group were 73.81%, 67.50%, 67.57%, 65.22% and 44%, respectively, which were significantly higher than those in the control group (p < 0.05). In addition, patients taking botanical lozenges had better illness perception and adherence to treatment than those taking placebos (p < 0.05). Patients with low adherence to treatment showed less personal control, concerns, and understanding of chronic pharyngitis (p < 0.05). Conclusion: Botanical lozenges not only aided patients in recovering from chronic pharyngitis but also improved their positive perceptions of the disease, which helped them adhere to their treatment regimen. Clinical Trial Registration: [https://www.chictr.org.cn/], identifier [ChiCTR2200062139]. Copyright © 2024 Wu, Zhang, Kuang, Li, Yan, Yang, Wang, Wang, Sun, Liu, Xia and Cao. DOI: 10.3389/fphar.2024.1162883 PMCID: PMC10973001 PMID: 38549665 Conflict of interest statement: FZ was employed by the Yixing Institute of Food and Biotechnology Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
2. J Anim Physiol Anim Nutr (Berl). 2012 Apr;96(2):285-94. doi: 10.1111/j.1439-0396.2011.01151.x. Epub 2011 May 2. Effects of dietary supplementation of Chinese medicinal herbs on polymorphonuclear neutrophil immune activity and small intestinal morphology in weanling pigs. Huang CW(1), Lee TT, Shih YC, Yu B. Author information: (1)Department of Animal Science, National Chung Hsing University, Taichung, Taiwan, China. The purpose of this study was to evaluate the effects of dietary Chinese medicinal herbs (CMH) supplementation composed of Panax ginseng, Dioscoreaceae opposite, Atractylodes macrocephala, Glycyrrhiza uralensis, Ziziphus jujube and Platycodon grandiflorum, on the performance, intestinal tract morphology and immune activity in weanling pigs. Two hundred and forty weaned pigs were assigned randomly to four dietary groups including the negative control (basal diet), 0.1% CMH, 0.3% CMH and 0.114% antibiotic (Chlortetracycline calcium Complex, Sulfathiazole and Procaine Penicillin G) supplementation groups for a 28-day feeding trial. Results indicated that both CMH supplementation groups had a better gain and feed/gain than control group (CT) during the first 2 weeks of the experimental period. The 0.3% CMH had a significant decrease in the diarrhoea score in first 10 days of experimental period when compared with other groups. The CMH supplementation groups had a higher villous height, increased lactobacilli counts in digesta of ileum and decreased coliform counts in colon compared with CT. The immune activities of polymorphonuclear leucocytes (PMNs), including the respiratory burst and Salmonella-killing ability, were significantly enhanced in CMH supplementation groups at day 7 of experiment period. The CMH and antibiotic supplementations increased the nutrient digestibility such as dietary dry matter, crude protein and gross energy in weanling pigs. In conclusion, the dietary CMH supplementation improved intestinal morphology and immune activities of PMNs, thus giving rise to nutrient digestibility and reduce diarrhoea frequency in weanling pigs. © 2011 Blackwell Verlag GmbH. DOI: 10.1111/j.1439-0396.2011.01151.x PMID: 21535231 [Indexed for MEDLINE]
3. Front Plant Sci. 2025 Feb 11;16:1535170. doi: 10.3389/fpls.2025.1535170. eCollection 2025. Saponin content in medicinal plants in response to application of organic and inorganic fertilizers: a meta-analysis. Lv J(#)(1)(2), Liu S(#)(1)(3), Hu C(4), Ding L(5), Wang H(1)(3), Li X(2), Yang F(1)(3), Shen Q(1)(3), Zhang H(1)(3), Ma G(1)(3), Zhang S(2), Bai Y(1)(3). Author information: (1)College of Food and Health, Zhejiang Agriculture and Forestry University, Hangzhou, China. (2)Tea Research Institute, Chinese Academy of Agricultural Sciences, Hangzhou, China. (3)State Key Laboratory of Subtropical Silviculture, Zhejiang Agriculture and Forestry University, Hangzhou, China. (4)Food and Drug Inspection and Testing Center, Hangzhou, China. (5)Agriculture and Forestry Technology Extension Center, Hangzhou, China. (#)Contributed equally The application of fertilizers is a key agronomic practice in the artificial cultivation of medicinal plants, aiming to boost yields and enhance the levels of their bioactive constituents. However, systematic investigations on the influence of various fertilizers on the concentration of active compounds in saponin-containing medicinal plants remain insufficient. In this study, 966 experimental outcomes from 29 papers were analyzed via meta-analysis to examine the effects of organic fertilizers, inorganic fertilizers, and their combined application on the levels of different saponin monomers in medicinal plants. The findings from the meta-analysis revealed that inorganic fertilizers contribute positively to the accumulation of saponins such as Rg1 in ginseng, Rb1, Rc, Rd, Re, and Rg1, in addition to the saponins from Paris polyphylla, Dioscorea, Panax quinquefolius, and Platycodon grandiflorus. Moreover, the application of organic fertilizers was found to markedly elevate the concentrations of Notoginsenoside R1, Ginsenoside Rb1, Ginsenoside Rb2, Re, and Rg1, along with Lancemasid saponins and Quinoa saponins. The combined use of both organic and inorganic fertilizers was shown to effectively increase the levels of Notoginsenoside R1 and Panax ginsenosides, encompassing Rb1, Rb2, Rc, Rd, Re, and Rg1. Overall, the results suggest that both individual and combined applications of organic and inorganic fertilizers have a positive impact on the enhancement of saponin monomers in medicinal plants. However, inorganic fertilizers promote the increase of saponin content, their prolonged use may lead to soil compaction and acidification, which could compromise the yield and quality of medicinal plants. On the other hand, organic fertilizers improve the soil environment and stimulate saponin accumulation, they do not supply all the nutrients required for the sustained growth of these plants. Therefore, a balanced fertilization strategy combining both organic and inorganic fertilizers is recommended as the optimal approach for cultivating saponin-rich medicinal plants. Copyright © 2025 Lv, Liu, Hu, Ding, Wang, Li, Yang, Shen, Zhang, Ma, Zhang and Bai. DOI: 10.3389/fpls.2025.1535170 PMCID: PMC11851015 PMID: 40007964 Conflict of interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
4. J Integr Complement Med. 2022 Sep;28(9):768-774. doi: 10.1089/jicm.2021.0433. Epub 2022 May 31. Kikyo-to for Acute Upper Respiratory Tract Infection-Associated Sore Throat Pain: A Multicenter Randomized Controlled Trial. Ishimaru N(1), Suzuki S(2), Shimokawa T(3), Iijima K(2), Kanzawa Y(1), Nakajima T(1), Kinami S(1). Author information: (1)Department of General Internal Medicine, Akashi Medical Center, Hyogo, Japan. (2)Department of General Medicine, Tone Chuo Hospital, Numata, Japan. (3)Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan. Objectives: Kikyo-to (Kt), a herbal medicine composed of glycyrrhiza root (Chinese licorice) and Platycodon root extracts (Chinese bellflower), is commonly used in Japan for relief of throat symptoms related to acute upper respiratory tract infection (URTI). Its effectiveness on URTI-associated sore throat pain over 30 min is examined here in comparison with a placebo. Design: Randomized double-blinded multicenter trial. Settings/Location: Two local Japanese medical centers with primary care. Subjects: Patients aged 20-65 years with URTI-related sore throat. Interventions: Patients were randomized to receive either 2500 mg of Kt, or 2500 mg of placebo (lactose). Randomization was stratified by age (< 45 vs. ≥ 45 years) and baseline sore throat score according to visual analogue scale (VAS) (< 50 vs. ≥ 50). Outcome measures: Primary outcome was change to sore throat score according to VAS 30 min after administration of Kt. Perceived impact of the sore throat on daily life at 30 mins after administration was another outcome. Outcomes are analyzed in the intention-to-treat population. Results: Among 70 participants, (Kt group: 36; placebo group: 34), each group contained 34 patients for analysis (n = 68, total). Difference between the groups in the mean change of sore throat score according to VAS at 30 min was without statistical significance (Kt 15.3, placebo 17.2; p = 0.66). Patients reporting that their sore throat had a moderate or greater impact on daily life were also similar in proportion between the groups (Kt 61.8% vs. placebo 55.9%; p = 0.80). Side effects were not reported. Conclusions: Kt did not relieve acute URTI-associated sore throats significantly more than a placebo. (UMIN trial ID: UMIN000035591). DOI: 10.1089/jicm.2021.0433 PMID: 35648044 [Indexed for MEDLINE]
5. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420945017. doi: 10.1177/1534735420945017. Platycodon grandiflorum Protects Against Anthracycline-Induced Cardiotoxicity in Early Breast Cancer Patients. Hao W(1), Shi Y(1), Qin Y(1), Sun C(1), Chen L(1), Wu C(1), Bao Y(1), Liu S(1). Author information: (1)Long Hua Hospital, Shanghai, China. Background: Anthracycline-based chemotherapy is an effective treatment used for early-stage breast cancer patients. However, anthracycline use is limited due to its cardiotoxic effects. Recent studies have shown that Platycodon grandiflorum (PG) protects the heart from anthracycline-induced cardiotoxicity. However, no randomized, placebo-controlled clinical trial has been performed to investigate the clinical use of PG to prevent anthracycline-induced cardiotoxicity. This study aimed to evaluate the cardioprotective effects and safety of PG in early breast cancer patients receiving anthracycline-based chemotherapy. Methods: A total of 125 early breast cancer patients receiving anthracycline-based chemotherapy were enrolled and randomized into a PG group or placebo group in a 1:1 ratio. Results: Only 2 (3.1%) participants in the placebo group and 1 (1.6%) participant in the PG group experienced NYHA (New York Heart Association) class III or IV heart failure. There were no significant differences observed between the 2 groups. However, compared with the placebo group, patients in the PG group showed a lower incidence of subclinical heart failure (21.9% vs 8.2%, respectively, P = .033), as well as lower cardiac troponin T levels (48.4% vs 31.1%, respectively, P = .002). Importantly, there were no differences observed in the antitumor effects of anthracycline between the 2 groups (disease-free survival: hazards ratio = 1.09, 95% confidence interval = 0.45-2.62, P = .84; overall survival: hazards ratio = 1.46, 95% confidence interval = 0.33-6.43, P = .62). Conclusion: PG prevents anthracycline-induced acute and chronic cardiac injury in early-stage breast cancer patients without compromising the antitumor effects of chemotherapy. DOI: 10.1177/1534735420945017 PMCID: PMC7491211 PMID: 32729334 [Indexed for MEDLINE] Conflict of interest statement: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
6. Biomed Pharmacother. 2020 May;125:109900. doi: 10.1016/j.biopha.2020.109900. Epub 2020 Feb 3. Data mining and systematic pharmacology to reveal the mechanisms of traditional Chinese medicine in Mycoplasma pneumoniae pneumonia treatment. Sun JH(1), Sun F(2), Yan B(3), Li JY(4), Xin L(5). Author information: (1)Tropical Medicine Research Institute, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050,China. Electronic address: 1260798143@qq.com. (2)The Center for Biomedical Research, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: phil_sunfei@163.com. (3)Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. Electronic address: 545020728@qq.com. (4)Department of Integrated Traditional Chinese and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: lijunyi19901990@163.com. (5)Tropical Medicine Research Institute, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050,China. Electronic address: xindl48@126.com. Traditional Chinese Medicine (TCM) is widely used in the treatment of Mycoplasma pneumoniae Pneumonia (MPP) in East Asia. However, our current understanding of the underlying molecular mechanism remains dispersive and promiscuous. In this study, a systematic pharmacological approach combined with literature data mining was applied for drug similarity evaluation, drug half-life evaluation, oral bioavailability prediction, drug target exploration, Gene Ontology (GO) analysis, KEGG pathway enrichment and network construction, thus providing the rationale for its clinical performance. Five mostly studied herbs, including Ephedra Herba, Amygdalus communis Vas, Platycodon grandiforus, Licorice and Scutellariae Radix, were selected from the literature. Total ninety-three active ingredients, which are expected to be the effective components for MPP treatment, were screened out. Interrelationship between active compounds, drug targets and signaling pathways were analyzed to reveal the therapeutic effect of TCM in detail. Of importance, we found that TNF, β2AR and PTGS2 play pivotal role in TCM mediated MPP inhibition. And mechanistically, epithelial apoptosis (defensive barrier function), GPCR signaling (symptom amelioration) and immune pathways (innate signaling and adaptive Th17 response) are critically involved. Our work, achieved through systematic pharmacology and data mining, enlarges the knowledge of TCM in MPP therapy, and could provide valuable insights for further drug discovery studies. Copyright © 2020. Published by Elsevier Masson SAS. DOI: 10.1016/j.biopha.2020.109900 PMID: 32028237 [Indexed for MEDLINE] Conflict of interest statement: Declaration of Competing Interest The authors declare no conflict of interest.
7. Intern Med. 2019 Sep 1;58(17):2459-2465. doi: 10.2169/internalmedicine.2748-19. Epub 2019 Jun 7. Kikyo-to vs. Placebo on Sore Throat Associated with Acute Upper Respiratory Tract Infection: A Randomized Controlled Trial. Ishimaru N(1), Kinami S(1), Shimokawa T(2), Kanzawa Y(1). Author information: (1)Department of General Internal Medicine, Akashi Medical Center, Japan. (2)Clinical Study Support Centre, Wakayama Medical University, Japan. Objective Kikyo-to (KKT) is a fixed combination of glycyrrhiza root and platycodon root extracts. It is an herbal medicine traditionally used in Japan for relieving sore throat associated with acute upper respiratory tract infection (URTI). No controlled studies have yet demonstrated its effect, however. We investigated the efficacy of KKT on sore throat associated with acute URTI. Methods Patients with sore throat who were diagnosed with URTI at the General Medicine Department Office, Akashi Medical Center Hospital, between December 2017 and May 2018 were enrolled. Participants were randomly assigned to two groups at a 1:1 ratio, with stratification by age and sore throat score on a Visual Analogue Scale (VAS), to receive 2.5 g of either KKT or a placebo. Participants and investigators were blinded to group allocation. The primary outcome was the change in sore throat score on VAS 10 minutes after KKT administration. Secondary outcomes were the impact of the sore throat on daily life (none, mild, moderate, and severe) at 10 minutes after administration. Results Thirty-five participants were assigned to each group (n=70, total). The difference in the mean change of sore throat score according to VAS within 10 minutes between the two groups was not statistically significant (KKT 14.40 vs. placebo 17.00; p=0.39). The proportion of patients with a moderate or greater impact of their sore throat on their daily life was also not significantly different between the groups (KKT 22.9% vs. placebo 40.0%; p=0.20). Patients reported no side effects. Conclusion KKT did not significantly relieve sore throat associated with acute URTI compared with placebo. DOI: 10.2169/internalmedicine.2748-19 PMCID: PMC6761347 PMID: 31178508 [Indexed for MEDLINE] Conflict of interest statement: The authors state that they have no Conflict of Interest (COI).
8. Zhongguo Zhen Jiu. 2016 Dec 12;36(12):1257-1262. doi: 10.13703/j.0255-2930.2016.12.009. [Clinical observation of post-infectious cough differentiated as wind-cold retention in the lung treated with scraping therapy and xuanfei zhisou decoction]. [Article in Chinese] Hu Q(1), Wang Q(2), Duan P(1), Meng F(1), Gong X(1), Hu S(1), Zhu X(1). Author information: (1)First Affiliated Hospital of Nanjing University of CM, Nanjing 210029, Jiangsu Province, China. (2)Nursing School, Nanjing University of CM. OBJECTIVE: To compare the difference in the therapeutic effect on post-infectious cough differentiated as wind-cold retention in the lung between the combined therapy of scraping and xuanfei zhisou decoction and the simple application of xuanfei zhisou decoction. METHODS: Eighty patients were randomized into a combined therapy group and a Chinese herbal medicine group, 40 cases in each one. In the Chinese herbal medicine group, the oral administration of xuanfei zhisou decoction was used. The main ingredients included roasted herba ephedrae, amygdalus communis vas, rhizoma zingiberis recens, platycodon grandiflorum, flos farfarae, pinellia temata, radix stemonae, herba periliae, etc., one dose a day, twice a day. In the combined therapy group, on the basis of the treatment as the Chinese herbal medicine group, scraping therapy was added and applied to the bladder meridian of foot-taiyang, the lung meridian of hand-taiyin, the conception vessel and the governor vessel, focusing on Tiantu (CV 22), Baihui (GV 20), Dazhui (GV 14), Feishu (BL 13), Fengmen (BL 12), Taiyuan (LU 9), Lieque (LU 7) and Fengchi (GB 20), once a week and one-week treatment as one session. Totally, the continuous two sessions were required in the two groups. The cough symptom score, cough remission time, relapse, TCM syndrome score, the score of Leicester cough questionnaire (LCQ), SP concentration in the supernatant of the induced sputum before and after treatment as well as clinical efficacy were observed in the two groups. RESULTS: The cough symptom score, TCM symptom score and SP concentration in the supernatant of the induced sputum were all apparently reduced after treatment in the patients of the two groups (all P<0.01). The scores in the combined therapy group were reduced in the higher amplitude as compared with those in the Chinese herbal medicine group (all P<0.01). The total effective rate was 95.0% (38/40) in the combined therapy group, better than 87.5% (35/40) in the Chinese herbal medicine group (P<0.05). Regarding the cough remission time and relapse rate, the results in the combined therapy group were better than those in the Chinese herbal medicine group[(5.3±1.2) d vs (7.4±1.5) d, P<0.01; 0% (0/19) vs 62.5% (5/8), P<0.01]. The scoreo of LCQ was all apparently improved in the patients of the two groups (both P<0.01), and the score in the combined therapy group was higher than that in the Chinese herbal medicine group (P<0.01). CONCLUSIONS: Scraping therapy combined with xuanfei zhisou decoction and the simple application of xuanfei zhisou decoction all relieve the symptoms of post-infectious cough and improves the living quality. The therapeutic effects of the combined therapy are superior to the oral administration of xuanfei zhisou decoction. DOI: 10.13703/j.0255-2930.2016.12.009 PMID: 29231362 [Indexed for MEDLINE]
9. Trials. 2017 Aug 22;18(1):386. doi: 10.1186/s13063-017-2140-z. Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial. Hao W(1), Liu S(2), Qin Y(1), Sun C(1), Chen L(1), Wu C(1), Bao Y(1). Author information: (1)Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China. (2)Department of Breast Surgery (Integrated Traditional and Western Medicine), Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Xuhui District, Shanghai, 200032, China. lshtcm@163.com. BACKGROUND: Anthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-associated dose-dependent cardiotoxicity is a limiting factor in clinical use. Extensive efforts have been devoted to identifying strategies to prevent anthracycline-induced cardiotoxicity. However, most cardioprotective agents have shown little effect in clinical trials. Herbal medicines are pure, natural substances that have been used for centuries in many countries, including China. This trial aims to evaluate the cardioprotective effects and safety of Platycodon grandiflorum granules compared to placebo granules in patients with early breast cancer receiving anthracycline-based chemotherapy. METHOD/DESIGN: This study is a single-center, double-blinded, randomized, placebo-controlled, parallel-group trial. A total of 120 patients will be randomly allocated in a 1:1 ratio to receive either P. grandiflorum granules or placebo granules twice daily for 12 weeks. The primary outcome is heart failure (either clinical or subclinical). The secondary outcomes include all-cause mortality, cardiac death, electrocardiogram (ECG) findings, left ventricular diastolic function, longitudinal systolic strain and velocities measured by tissue Doppler imaging, cardiac biomarkers, such as troponin I (TnI), brain natriuretic peptide (BNP), and creatine kinase isoenzymes (CK-MB). Assessments will be performed at baseline (before randomization) and 3, 6, 9, 12, 16, and 20 weeks after randomization. DISCUSSION: This will be the first clinical trial to evaluate the cardioprotective effects and safety of P. grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future. TRAIL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-16009256 . Registered on 23 September 2016. DOI: 10.1186/s13063-017-2140-z PMCID: PMC5568055 PMID: 28830541 [Indexed for MEDLINE] Conflict of interest statement: AUTHORS’ INFORMATION: Sheng Liu, MD, professor, MD supervisor Graduated from Shanghai University of Traditional Chinese Medicine. Vice president of Longhua Hospital affiliated to Shanghai University of Traditional Chinese. Chief Physician of department of Breast Surgery (Integrated Traditional and Western Medicine). Director of Pharmacology Laboratory of traditional Chinese Medicine. ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The study protocol was outlined according to both the Declaration of Helsinki and GCP guidelines. The study protocol and informed consent document have been approved by the Ethics Committee of Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine (reference number 2015LCSY14). An informed consent file will be obtained and kept for each study participant. Any modifications to the protocol or informed consent document must be approved by the relevant ethics committee before being implemented. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: The authors declare that they have no competing interests. PUBLISHER’S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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